Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life

Not Applicable

• Conditions: Heart Diseases; Implantable Cardioverter-Defibrillators

• Registration Number: NCT00895700
• Lead Sponsor: Tilburg University

Brief Summary

The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet.

The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Study Start: 2010-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19
• Primary Completion: 2013-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• patients implanted with a cardioverter-defibrillator (ICD)
• between 18-75 years of age
• speaking and understanding Dutch
• with access to the internet and ability to use the internet
• providing written informed consent

Exclusion Criteria

• a life expectancy less than 1 year
• a history of psychiatric illness other than affective/anxiety disorders
• on the waiting list for heart transplantation
• with insufficient knowledge of the Dutch language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety	52 weeks
Anxiet	26 weeks

Secondary Outcome Measures

Name	Time	Method
Cortisol awakening response	52 weeks

Trial Locations

Locations (6)

Canisius-Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands

Amphia Hospital; 🇳🇱 Breda, Noord Brabant, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

Onze Lieve Vrouwe Gasthuis (OLVG); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Vlietland Ziekenhuis; 🇳🇱 Schiedam, Netherlands